Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease

NCT03142529 | Unknown Phase 1 DMC

• 1 other identifier: CRF-CD2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood dialysis therapy in adults. Half of participants will receive conventional integrated therapy on chronic renal failure (CRF), while the other half will receive integrated therapy on CRF and traditional Chinese medicine colonic dialysis.

Conditions

Chronic Kidney Failure; End-Stage Kidney Disease

Keywords

Non dialysis

Outcome Measures

Primary Outcomes (2)

• Change of glomerular filtration rate index

  measuring the level of urea nitrogen，blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineβ2-microglobulin. calculating the creatinine clearance rate.

  the first day before intervention and the eleventh day

• Change of intestinal flora

  measuring serum endotoxin and investigating the differences of intestinal flora between control group and experience group，as well as the differences between before colonic dialysis and after colonic dialysis.

  the first day before intervention and the eleventh day

Secondary Outcomes (3)

• Change of serum electrolyte changes

  the first day before intervention and the eleventh day

• Change of related inflammatory index

  the first day before intervention and the eleventh day

• Change of renal fibrosis index

  the first day before intervention and the eleventh day

Study Arms (2)

Integrated Therapy

NO INTERVENTION

This arm is an control group,in which participants will receive conventional integrated therapy on CRF.

Integrated Therapy and colonic dialysis

EXPERIMENTAL

This arm is a treatment group,in which participants will receive integrated therapy on CRF and traditional Chinese medicine Colonic dialysis with traditional Chinese medicine colon lotion once a day.

Drug: colon lotion

Interventions

colon lotion DRUG

The colon lotion used in this clinic trial is a kind of hospital preparation. It is brown liquid,which consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The colon lotion is diluted from 30ml to 150ml each time and will be used once a day for 10 days.

Also known as: YZ20071408

Integrated Therapy and colonic dialysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• corresponding to diagnosis standards of CKD-5:eGFR≤15ml/min/1.73m2; 2. did not receive kidney replacement therapy; 3. no gastrointestinal diseases (including ulcerative colitis, irritable bowel syndrome, inflammation, cancer, infection, bleeding, etc.) in the past 1 year; 4.not associated with rectal-related disorders (hemorrhoids, anal fistula, rectal cancer, cancer, infection, bleeding, etc.); 5.Sign informed consent.

You may not qualify if:

• \. having used antibiotics, hormones, immunosuppressive, probiotics and laxatives in past three months; 2. pregnant or lactating patients; 3.cannot cooperate or tolerate colonic dialysis treatment; 4.combined with active stage of malignant tumors, cardiovascular, respiratory system, decompensated liver cirrhosis or blood system diseases (including coagulation disorders, hematopoietic dysfunction, etc.) and other serious primary disease; 5. recent merger of patients with infectious diseases; 6.having known to be allergic to some drugs in the study.

Sponsors & Collaborators

• Pang Peng: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510006, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chen X Yin, Ph.D

  Jinan University Guangzhou

  STUDY CHAIR

• Bao Kun

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

• Pang Peng

  Jinan University Guangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pang Peng

CONTACT

01186-15099960366; pangpeng@stu2014.jnu.edu.cn

Chen X Yin, Ph.D

CONTACT

01186-13822263950; tchenxiaoyin@jnu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 5, 2017
• Study Start: May 15, 2017
• Primary Completion: August 15, 2018
• Study Completion: October 15, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)